Obstructive Sleep ApneaNCT03230877

The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

A study testing Toffee full face mask with 'Improved Seal' and Toffee full face mask with 'Normal Seal' in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Toffee full face mask with 'Improved Seal' and Toffee full face mask with 'Normal Seal'
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2017to 30 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult (22+ years of age)
Able to give informed consent
Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
Fluent in spoken and written English
Existing F\&P full face mask user

Who cannot join

Inability to give informed consent
Participant intolerant to PAP
Anatomical or physiological conditions making PAP therapy inappropriate
Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
Pregnant or may think they are pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Trials of Florida
Miami, Florida, 33186

Other trials in United States

About this study

Read the detailed description

This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.

The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.

Visit Three will involve the participants returning the second trial seal and providing feedback.

Conditions: Obstructive Sleep Apnea
Being tested: Toffee full face mask with 'Improved Seal', Toffee full face mask with 'Normal Seal'
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Toffee full face mask with 'Improved Seal'Device
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
Toffee full face mask with 'Normal Seal'Device
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.

Study groups in NCT03230877
Study group	Role	What they receive
Group A	Experimental	Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2. Receives: Device: Toffee full face mask with 'Improved Seal'; Device: Toffee full face mask with 'Normal Seal'
Group B	Experimental	Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2. Receives: Device: Toffee full face mask with 'Improved Seal'; Device: Toffee full face mask with 'Normal Seal'

What is being measured

The primary outcome is the main question the study is designed to answer.

Trial Mask Seal Comfort
Overall seal comfort determined from questionnaires- Subjective
Measured: 7 ± 4 days in-home
Trial Mask Seal Acceptability
Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Measured: 14 ± 4 days in-home

Secondary outcomes (3)

Trial Mask Seal Treatment Performance - Objective
Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
Measured: 7 ± 4 days in-home
Trial Mask Seal Usability
Usability interview during first visit- Subjective
Measured: 1 hour day-time appointment
Trial Mask Seal Treatment Performance- Subjective
Seal performance determined from questionnaires - Subjective
Measured: 7 ± 4 days in-home

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 201730 Nov 2017

First posted27 Jul 2017
Study start2 Sep 2017
Primary completion30 Nov 2017
Study completion30 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03230877
Sponsor's protocol ID: CIA-223
Status last verified: Aug 2022
First submitted: 24 Jul 2017
Last updated: 8 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: This investigation is to inform product development team. Results will inform product development on the future of the product.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT03230877
Acronym / sponsor ID: CIA-223
Conditions: Obstructive Sleep Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
Study start: 2 Sep 2017 (actual)
Primary completion: 30 Nov 2017 (actual)
Study completion: 30 Nov 2017 (actual)
First posted: 27 Jul 2017 (actual)
Results: Posted 8 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.

Visit Three will involve the participants returning the second trial seal and providing feedback.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: Toffee full face mask with 'Improved Seal', Device: Toffee full face mask with 'Normal Seal'Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Group B	Experimental	Device: Toffee full face mask with 'Improved Seal', Device: Toffee full face mask with 'Normal Seal'Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult (22+ years of age)
Able to give informed consent
Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
Fluent in spoken and written English

Key exclusion criteria (5 listed)

Inability to give informed consent
Participant intolerant to PAP
Anatomical or physiological conditions making PAP therapy inappropriate
Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
Pregnant or may think they are pregnant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Toffee full face mask with 'Improved Seal'Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.	Device	Group A, Group B
Toffee full face mask with 'Normal Seal'Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.	Device	Group A, Group B

Primary outcome

Trial Mask Seal Comfort
Time frame: 7 ± 4 days in-home
Overall seal comfort determined from questionnaires- Subjective
Trial Mask Seal Acceptability
Time frame: 14 ± 4 days in-home
Preference for trial mask determined from questionnaires at the end of the trial - Subjective

3 secondary outcomes

Trial Mask Seal Treatment Performance - Objective
Time frame: 7 ± 4 days in-home
Trial Mask Seal Usability
Time frame: 1 hour day-time appointment
Trial Mask Seal Treatment Performance- Subjective
Time frame: 7 ± 4 days in-home

Results and safety

Results posted to the registry on 8 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Seal Then Improved Seal	23	23
Improved Seal Then Normal Seal	15	15

Primary outcome: Trial Mask Seal Comfort

Time frame: 7 ± 4 days in-home. Count of participants. Unit: Participants

Measure	Toffee Full Face Mask With 'Improved Seal' n = 38	Toffee Full Face Mask With 'Normal Seal' n = 38
Very comfortable	16	13
Comfortable	16	19
Neither comfortable nor uncomfortable	2	1
Uncomfortable	3	3
Very uncomfortable	0	1
N/A	1	1

Primary outcome: Trial Mask Seal Acceptability

Time frame: 14 ± 4 days in-home. Count of participants. Unit: Participants

Measure	Total Trial Population n = 38
Preferred "Improved seal"	19
Preferred "Normal seal"	15
No preference	3
N/A	1

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for all participants during the 2 month study period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Toffee Full Face Mask With 'Improved Seal'	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Toffee Full Face Mask With 'Normal Seal'	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. This investigation is to inform product development team. Results will inform product development on the future of the product.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trial Mask Seal Comfort (time frame: 7 ± 4 days in-home). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03230877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.